Crohn's Disease, Ulcerative Colitis (Part 2 Only)
Conditions
Brief summary
Phase 1 randomized, open-label, multicenter, parallel-group study designed to evaluate efficacy, pharmacokinetics and safety between CT-P13 subcutaneous (SC) and CT-P13 intravenous (IV) in patients with active Crohn's Disease (CD) and active Ulcerative Colitis (UC).
Detailed description
A new subcutaneous infliximab formulation is developed by Celltrion, Inc. as an alternative to the intravenous regimen where subcutaneous infliximab injection typically takes less than 2 minutes. The availability of a subcutaneous formulation of infliximab would increase the treatment options available to patients, particularly those wishing to self-administer their therapy. This Phase 1 randomized, open-label, multicenter, parallel-group study is designed to evaluate efficacy, pharmacokinetics and safety between CT-P13 SC and CT-P13 IV in patients with active CD and active UC.
Interventions
BIOLOGICALCT-P13
CT-P13 (5 mg/kg) by IV infusion administered as a 2-hour IV infusion per dose every 8 weeks (Part 1)
Sponsors
Celltrion
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patient has active Crohn's disease with a score on the Crohn's disease activity index between 220 and 450 points. * Patient has active Ulcerative colitis as defined by a total Mayo score between 6 and 12 points (Part 2 only).
Exclusion criteria
* Patient who has previously received a biological agent for the treatment of CD and UC and/or a tumor necrosis factor-alpha (TNFα) inhibitor for the treatment of other disease * Patient who has allergies to any of the excipients of infliximab or any other murine and/or human proteins or patient with a hypersensitivity to immunoglobulin product * Patient who has a current or past history of infection with HIV, hepatitis B, or hepatitis C (carriers of hepatitis B and hepatitis C are not permitted to enrol into the study, but past hepatitis B resolved can be enrolled) * Patient who has acute infection requiring oral antibiotics within 2 weeks or parenteral injection of antibiotics within 4 weeks prior to the first administration of the study drug, other serious infection within 6 months prior to the first administration of study drug or recurrent herpes zoster or other chronic or recurrent infection within 6 weeks prior to the first administration of the study drug * Patient who has an indeterminate result for interferon-γ release assay (IGRA) or latent tuberculosis (TB) at Screening. For Part 2, if IGRA result is indeterminate at Screening, 1 retest will be possible during the screening. If the repeated IGRA result is negative, the patient can be included in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Descriptive Statistics of Area Under the Concentration-time Curve (AUCτ) of Infliximab at Steady State (Part 1) | Week 22, 24, 26 and 28 | For Part 1, the primary PK endpoint of the AUCτ at steady state between Week 22 and Week 30 was analyzed in patients who received all doses (full) of study drug up to Week 30 (prior to Week 30) in the PK population. All patients in SC cohorts were randomly assigned at Week 14 in a 1:1 ratio to either of Group A or B for PK monitoring visit period (Week 22 to Week 30). Therefore, AUCτ was calculated at Week 22 for Cohort 1: CT-P13 IV 5 mg/kg, Weeks 22 and 26 for Group A of SC cohorts, and Week 24 and 28 for Group B of SC cohorts. |
| Analysis of Covariance Model (ANCOVA) of Observed Ctrough,week22 (Pre-dose Level at Week 22) (Part 2) | Week 22 | For Part 2, the primary endpoint was to demonstrate that CT-P13 SC is non-inferior to CT-P13 IV, in terms of pharmacokinetics, as determined by the observed Ctrough,week22 (pre-dose level at Week 22). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Descriptive Statistics for Actual Value of Partial Mayo Score (Part 2 - UC) | up to Week 54 | For evaluation of efficacy, the secondary endpoint was defined as descriptive statistics for actual value of partial Mayo score up to Week 54 between the CT-P13 SC and CT-P13 IV treatment groups in active UC patients. The partial Mayo scores range from 0-9 with higher scores indicating increased severity of disease. The index is sum of the 3 subscores, each which range from 0 to 3; stool frequency, rectal bleeding and physician's global assessment. Efficacy assessments were done prior to each study drug administrations. Results up to Week 6 in both arms represent efficacy resulting from CT-P13 IV (5 mg/kg) loading dose treatment. |
| Proportion of Patients Achieving Clinical Response According to the Partial Mayo Score (Part 2 - UC) | up to Week 54 | For evaluation of efficacy, the secondary endpoint was defined as proportion of patients achieving clinical response according to the partial Mayo score up to Week 54 between the CT-P13 SC and CT-P13 IV treatment groups in active UC patients. Efficacy assessments were done prior to each study drug administrations. Results up to Week 6 in both arms represent efficacy resulting from CT-P13 IV (5 mg/kg) loading dose treatment. Responder according to partial Mayo score was defined as a decrease from baseline in partial Mayo score of at least 2 points, with an accompanying decrease in the subscore for rectal bleeding of at least 1 point or an absolute subscore for rectal bleeding of 0 or 1. |
| Descriptive Statistics for Actual Value of Crohn's Disease Activity Index (CDAI) Score (Part 2 - CD) | up to Week 54 | For evaluation of efficacy, the secondary endpoint was defined as descriptive statistics for actual value of CDAI score up to Week 54 between the CT-P13 SC and CT-P13 IV treatment groups in active CD patients. The total CDAI scores range from 0 to over 600 with higher scores indicating increased severity of disease. The index is the sum of 8 components multiplied by the relevant weight factor; number of liquid or very soft stools (x2), abdominal pain (x5), general well-being (x7), CD complications (x20), taking lomotil/opiates for diarrhea (x30), abdominal mass (x10), deviation of hematocrit (x6), and percentage deviation from standard weight (x1). Efficacy assessments were done prior to each study drug administrations. Results up to Week 6 in both arms represent efficacy resulting from CT-P13 IV (5 mg/kg) loading dose treatment. |
| Descriptive Statistics for Actual Value in Fecal Calprotectin Concentration (Pharmacodynamic Parameter) (Part 2) | up to Week 54 | For evaluation of pharmacodynamic (PD), the secondary endpoint was defined as concentration of Fecal Calprotectin (FC) between 2 treatment groups up to Week 54. The fecal samples for FC were collected at Weeks 0, 2 and 6, and every 8 weeks up to Week 54. All enrolled patients received CT-P13 IV infusions at Weeks 0 and 2. Then, patients in CT-P13 SC group were administered with CT-P13 SC at Week 6 and every 2 weeks thereafter up to Week 54. Patients in the CT-P13 IV group were administered with CT-P13 IV at Week 6 and every 8 weeks thereafter up to Week 22 (Weeks 14 and 22). And then, CT-P13 IV was switched to CT-P13 SC based on body weight at Week 30, and further doses with CT-P13 SC were given up to Week 54. All patients in the PD population were analyzed according to the treatment they received. |
| Descriptive Statistics of Observed Ctrough (Trough Concentration [Before the Next Study Drug Administration]) of Infliximab (Part 2) | up to Week 54 | For evaluation of pharmacokinetics (PK), the secondary endpoint was defined as the analysis of trough concentration of infliximab up to Week 54. The samples were collected at Weeks 0, 2 and 6, and every 8 weeks up to Week 54. During PK monitoring visit (Weeks 22-30), samples were collected every 2 weeks according steady state PK sampling time point. All enrolled patient received CT-P13 IV infusions at Weeks 0 and 2. Patients in SC group were administered with CT-P13 SC at Week 6 and every 2 weeks thereafter up to Week 54. Patients in IV group were administered with CT-P13 IV at Week 6 and every 8 weeks thereafter up to Week 22. Then, CT-P13 IV was switched to CT-P13 SC at Week 30, and further doses with CT-P13 SC were given up to Week 54. No PK results were obtained at Weeks 6 and 14 for SC group and Weeks 12, 20, 24, 26 and 28 for IV group due to 2 weeks and 8 weeks dosing interval, respectively. All patients in PK population were analyzed according to the treatment they received. |
| Proportion of Patients Achieving Clinical Response According to CDAI-100 Criteria (Part 2 - CD) | up to Week 54 | For evaluation of efficacy, the secondary endpoint was defined as proportion of patients achieving clinical response according to CDAI-100 criteria up to Week 54 between the CT-P13 SC and CT-P13 IV treatment groups in active CD patients. Efficacy assessments were done prior to each study drug administrations. Results up to Week 6 in both arms represent efficacy resulting from CT-P13 IV (5 mg/kg) loading dose treatment. Responder according to CDAI-100 criteria was defined as a decrease in CDAI score of 100 points or more from the baseline value. |
Countries
South Korea
Participant flow
Recruitment details
For Part 1, participants were screened from 21 study centers in 9 countries and were enrolled from 20 study centers in 9 countries. For Part 2, participants were screened from 62 study centers in 16 countries and were enrolled from 50 study centers in 15 countries.
Pre-assignment details
For Part 1, a total of 55 CD patients were screened, 45 patients were enrolled (10 screening failures) and 44 patients were randomized. For Part 2, a total of 195 CD and UC patients were screened, 136 patients were enrolled (59 screening failures) and 131 patients were randomized.
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1: CT-P13 IV 5 mg/kg (Part 1) Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received further 7 doses of CT-P13 IV 5 mg/kg (Infliximab) by IV infusion at Week 6 and every 8 weeks thereafter up to Week 54. | 13 |
| Cohort 2: CT-P13 SC 120 mg (Part 1) Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC 120 mg (Infliximab) with a 2-week interval from Week 6. The dose of SC 120 mg was adjusted to SC 120 or 240 mg every 2 weeks based on their body weight after Week 30 in applicable patients in Cohort 2: CT-P13 SC 120 mg. | 11 |
| Cohort 3: CT-P13 SC 180 mg (Part 1) Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC 180 mg (Infliximab) with a 2-week interval from Week 6. The dose of SC 180 mg was adjusted to SC 120 or 240 mg every 2 weeks based on their body weight after Week 30 in applicable patients in Cohort 3: CT-P13 SC 180 mg. | 12 |
| Cohort 4: CT-P13 SC 240 mg (Part 1) Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC 240 mg (Infliximab) with a 2-week interval from Week 6. The dose of SC 240 mg was adjusted to SC 120 or 240 mg every 2 weeks based on their body weight after Week 30 in applicable patients in Cohort 4: CT-P13 SC 240 mg. | 8 |
| Arm 1: CT-P13 SC 120/240 mg (Part 2) Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC (Infliximab) either 120 mg or 240 mg from Week 6 to Week 54 based on their body weight at Week 6 (CT-P13 SC 120 mg for patients \< 80 kg; CT-P13 SC 240 mg for patients ≥ 80 kg). | 66 |
| Arm 2: CT-P13 IV 5 mg/kg (Part 2) Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 IV 5 mg/kg (Infliximab) by IV infusion with a 8-week interval from Week 6 up to Week 22 (Weeks 6, 14 and 22). CT-P13 IV was switched to either 120 mg or 240 mg of CT-P13 SC treatment based on their body weight at Week 30 (CT-P13 SC 120 mg for patients \< 80 kg; CT-P13 SC 240 mg for patients ≥ 80 kg), and further doses with CT-P13 SC were given up to Week 54. | 65 |
| Total | 175 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 2 | 1 | 1 | 1 | 1 | 3 |
| Overall Study | Death | 1 | 0 | 1 | 0 | 0 | 0 |
| Overall Study | Disease progression | 1 | 0 | 0 | 1 | 4 | 5 |
| Overall Study | Other | 0 | 0 | 0 | 0 | 0 | 1 |
| Overall Study | Physician Decision | 0 | 0 | 0 | 0 | 4 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 1 | 3 | 0 | 2 | 5 |
Baseline characteristics
| Characteristic | Cohort 2: CT-P13 SC 120 mg (Part 1) | Cohort 3: CT-P13 SC 180 mg (Part 1) | Cohort 4: CT-P13 SC 240 mg (Part 1) | Cohort 1: CT-P13 IV 5 mg/kg (Part 1) | Arm 1: CT-P13 SC 120/240 mg (Part 2) | Arm 2: CT-P13 IV 5 mg/kg (Part 2) | Total |
|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 3 Participants | 2 Participants | 5 Participants |
| Age, Categorical >=65 years | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 4 Participants | 6 Participants | 11 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 12 Participants | 8 Participants | 13 Participants | 59 Participants | 57 Participants | 159 Participants |
| Age, Continuous | 33.0 years | 38.5 years | 42.0 years | 34.0 years | 33.0 years | 36.0 years | 36.0 years |
| Race/Ethnicity, Customized Asian/Oriental | 2 Participants | 3 Participants | 2 Participants | 2 Participants | 3 Participants | 4 Participants | 16 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized White/Caucasian | 9 Participants | 9 Participants | 6 Participants | 11 Participants | 62 Participants | 60 Participants | 157 Participants |
| Region of Enrollment Bosnia and Herzegovina | 0 participants | 0 participants | 0 participants | 0 participants | 1 participants | 0 participants | 1 participants |
| Region of Enrollment Bulgaria | 0 participants | 1 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants |
| Region of Enrollment Croatia | 0 participants | 0 participants | 1 participants | 3 participants | 2 participants | 1 participants | 3 participants |
| Region of Enrollment Czechia | 0 participants | 0 participants | 0 participants | 0 participants | 1 participants | 1 participants | 2 participants |
| Region of Enrollment Estonia | 1 participants | 0 participants | 0 participants | 0 participants | 0 participants | 3 participants | 3 participants |
| Region of Enrollment Germany | 0 participants | 0 participants | 0 participants | 0 participants | 4 participants | 0 participants | 4 participants |
| Region of Enrollment Hungary | 0 participants | 0 participants | 0 participants | 0 participants | 5 participants | 4 participants | 9 participants |
| Region of Enrollment Israel | 1 participants | 2 participants | 0 participants | 1 participants | 4 participants | 6 participants | 10 participants |
| Region of Enrollment Latvia | 1 participants | 2 participants | 0 participants | 3 participants | 2 participants | 6 participants | 8 participants |
| Region of Enrollment Poland | 0 participants | 0 participants | 0 participants | 0 participants | 20 participants | 23 participants | 43 participants |
| Region of Enrollment Portugal | 0 participants | 0 participants | 0 participants | 0 participants | 3 participants | 0 participants | 3 participants |
| Region of Enrollment Russia | 3 participants | 1 participants | 0 participants | 2 participants | 15 participants | 8 participants | 23 participants |
| Region of Enrollment Slovakia | 1 participants | 1 participants | 1 participants | 1 participants | 3 participants | 3 participants | 6 participants |
| Region of Enrollment South Korea | 2 participants | 3 participants | 2 participants | 2 participants | 1 participants | 4 participants | 5 participants |
| Region of Enrollment Spain | 0 participants | 0 participants | 0 participants | 0 participants | 3 participants | 2 participants | 5 participants |
| Region of Enrollment Ukraine | 2 participants | 2 participants | 4 participants | 1 participants | 2 participants | 4 participants | 6 participants |
| Sex: Female, Male Female | 3 Participants | 4 Participants | 4 Participants | 9 Participants | 30 Participants | 30 Participants | 80 Participants |
| Sex: Female, Male Male | 8 Participants | 8 Participants | 4 Participants | 4 Participants | 36 Participants | 35 Participants | 95 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 13 | 0 / 11 | 1 / 12 | 0 / 8 | 0 / 66 | 0 / 65 |
| other Total, other adverse events | 10 / 13 | 9 / 11 | 8 / 12 | 7 / 8 | 42 / 66 | 36 / 65 |
| serious Total, serious adverse events | 4 / 13 | 2 / 11 | 1 / 12 | 3 / 8 | 6 / 66 | 8 / 65 |
Outcome results
Primary
Analysis of Covariance Model (ANCOVA) of Observed Ctrough,week22 (Pre-dose Level at Week 22) (Part 2)
For Part 2, the primary endpoint was to demonstrate that CT-P13 SC is non-inferior to CT-P13 IV, in terms of pharmacokinetics, as determined by the observed Ctrough,week22 (pre-dose level at Week 22).
Time frame: Week 22
Population: The PK Population consisted of all-randomized population who received at least one full dose of study drug at Week 6 or thereafter, and who had at least one PK result after Week 6 treatment. The primary PK endpoint was analyzed in patients who received all doses (full) of study drug up to Week 22 (prior to Week 22) in the PK population.
| Arm | Measure | Value (GEOMETRIC_LEAST_SQUARES_MEAN) |
|---|---|---|
| Cohort 1: CT-P13 IV 5mg/kg (Part 1) | Analysis of Covariance Model (ANCOVA) of Observed Ctrough,week22 (Pre-dose Level at Week 22) (Part 2) | 20.9844 μg/mL |
| Cohort 2: CT-P13 SC 120 mg (Part 1) | Analysis of Covariance Model (ANCOVA) of Observed Ctrough,week22 (Pre-dose Level at Week 22) (Part 2) | 1.8181 μg/mL |
Comparison: Primary PK analysis was analyzed using an ANCOVA with treatment as fixed effect and current use of treatment with azathioprine (AZA) or 6-mercaptopurine (6-MP) or methotrexate (MTX) (used or not used), disease (CD or UC), clinical response at Week 6 (responder or non-responder by Clinical Disease Activity Index \[CDAI\]-70 for CD or partial Mayo score for UC), body weight at Week 6 (\<80 kg or ≥80 kg) fitted as covariates.90% CI: [786.37, 1694]
Primary
Descriptive Statistics of Area Under the Concentration-time Curve (AUCτ) of Infliximab at Steady State (Part 1)
For Part 1, the primary PK endpoint of the AUCτ at steady state between Week 22 and Week 30 was analyzed in patients who received all doses (full) of study drug up to Week 30 (prior to Week 30) in the PK population. All patients in SC cohorts were randomly assigned at Week 14 in a 1:1 ratio to either of Group A or B for PK monitoring visit period (Week 22 to Week 30). Therefore, AUCτ was calculated at Week 22 for Cohort 1: CT-P13 IV 5 mg/kg, Weeks 22 and 26 for Group A of SC cohorts, and Week 24 and 28 for Group B of SC cohorts.
Time frame: Week 22, 24, 26 and 28
Population: The PK population consisted of the all-randomized population who received at least one full dose of study drug at Week 6 or thereafter and who had at least one PK concentration result after Week 6 treatment. Among them, patients who received all doses (full) of study drug up to Week 30 (prior to Week 30) were included for primary PK analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: CT-P13 IV 5mg/kg (Part 1) | Descriptive Statistics of Area Under the Concentration-time Curve (AUCτ) of Infliximab at Steady State (Part 1) | Week 22 | 20825679.963 hr*ng/mL | Standard Deviation 8432154.3963 |
| Cohort 2: CT-P13 SC 120 mg (Part 1) | Descriptive Statistics of Area Under the Concentration-time Curve (AUCτ) of Infliximab at Steady State (Part 1) | Week 28 | 6589313.495 hr*ng/mL | Standard Deviation 984927.8419 |
| Cohort 2: CT-P13 SC 120 mg (Part 1) | Descriptive Statistics of Area Under the Concentration-time Curve (AUCτ) of Infliximab at Steady State (Part 1) | Week 22 | 7821587.111 hr*ng/mL | Standard Deviation 3104412.5348 |
| Cohort 2: CT-P13 SC 120 mg (Part 1) | Descriptive Statistics of Area Under the Concentration-time Curve (AUCτ) of Infliximab at Steady State (Part 1) | Week 24 | 7409271.434 hr*ng/mL | Standard Deviation 2062318.5332 |
| Cohort 2: CT-P13 SC 120 mg (Part 1) | Descriptive Statistics of Area Under the Concentration-time Curve (AUCτ) of Infliximab at Steady State (Part 1) | Week 26 | 8731448.964 hr*ng/mL | Standard Deviation 1799009.3658 |
| Cohort 3: CT-P13 SC 180 mg (Part 1) | Descriptive Statistics of Area Under the Concentration-time Curve (AUCτ) of Infliximab at Steady State (Part 1) | Week 24 | 6736990.881 hr*ng/mL | Standard Deviation 6632584.6372 |
| Cohort 3: CT-P13 SC 180 mg (Part 1) | Descriptive Statistics of Area Under the Concentration-time Curve (AUCτ) of Infliximab at Steady State (Part 1) | Week 22 | 12609504.125 hr*ng/mL | Standard Deviation 5112454.7748 |
| Cohort 3: CT-P13 SC 180 mg (Part 1) | Descriptive Statistics of Area Under the Concentration-time Curve (AUCτ) of Infliximab at Steady State (Part 1) | Week 28 | 7038910.791 hr*ng/mL | Standard Deviation 6502356.3807 |
| Cohort 3: CT-P13 SC 180 mg (Part 1) | Descriptive Statistics of Area Under the Concentration-time Curve (AUCτ) of Infliximab at Steady State (Part 1) | Week 26 | 11649915.371 hr*ng/mL | Standard Deviation 6140258.9463 |
| Cohort 4: CT-P13 SC 240 mg (Part 1) | Descriptive Statistics of Area Under the Concentration-time Curve (AUCτ) of Infliximab at Steady State (Part 1) | Week 28 | 14110560.823 hr*ng/mL | Standard Deviation 5628122.2174 |
| Cohort 4: CT-P13 SC 240 mg (Part 1) | Descriptive Statistics of Area Under the Concentration-time Curve (AUCτ) of Infliximab at Steady State (Part 1) | Week 22 | 9377712.620 hr*ng/mL | — |
| Cohort 4: CT-P13 SC 240 mg (Part 1) | Descriptive Statistics of Area Under the Concentration-time Curve (AUCτ) of Infliximab at Steady State (Part 1) | Week 24 | 14777046.642 hr*ng/mL | Standard Deviation 6894029.2838 |
| Cohort 4: CT-P13 SC 240 mg (Part 1) | Descriptive Statistics of Area Under the Concentration-time Curve (AUCτ) of Infliximab at Steady State (Part 1) | Week 26 | 9721425.240 hr*ng/mL | — |
Secondary
Descriptive Statistics for Actual Value in Fecal Calprotectin Concentration (Pharmacodynamic Parameter) (Part 2)
For evaluation of pharmacodynamic (PD), the secondary endpoint was defined as concentration of Fecal Calprotectin (FC) between 2 treatment groups up to Week 54. The fecal samples for FC were collected at Weeks 0, 2 and 6, and every 8 weeks up to Week 54. All enrolled patients received CT-P13 IV infusions at Weeks 0 and 2. Then, patients in CT-P13 SC group were administered with CT-P13 SC at Week 6 and every 2 weeks thereafter up to Week 54. Patients in the CT-P13 IV group were administered with CT-P13 IV at Week 6 and every 8 weeks thereafter up to Week 22 (Weeks 14 and 22). And then, CT-P13 IV was switched to CT-P13 SC based on body weight at Week 30, and further doses with CT-P13 SC were given up to Week 54. All patients in the PD population were analyzed according to the treatment they received.
Time frame: up to Week 54
Population: PD population - The PD population consisted of all randomly assigned patients who received at least 1 full dose of study drug (CT-P13 SC, CT-P13 IV) at Week 6 or thereafter, and who had at least 1 PD result after Week 6 treatment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: CT-P13 IV 5mg/kg (Part 1) | Descriptive Statistics for Actual Value in Fecal Calprotectin Concentration (Pharmacodynamic Parameter) (Part 2) | Week 2 | 697.0 μg/g | Standard Deviation 903.85 |
| Cohort 1: CT-P13 IV 5mg/kg (Part 1) | Descriptive Statistics for Actual Value in Fecal Calprotectin Concentration (Pharmacodynamic Parameter) (Part 2) | Week 30 | 555.8 μg/g | Standard Deviation 1032.33 |
| Cohort 1: CT-P13 IV 5mg/kg (Part 1) | Descriptive Statistics for Actual Value in Fecal Calprotectin Concentration (Pharmacodynamic Parameter) (Part 2) | Week 14 | 567.6 μg/g | Standard Deviation 751.53 |
| Cohort 1: CT-P13 IV 5mg/kg (Part 1) | Descriptive Statistics for Actual Value in Fecal Calprotectin Concentration (Pharmacodynamic Parameter) (Part 2) | Week 38 | 556.8 μg/g | Standard Deviation 1845.66 |
| Cohort 1: CT-P13 IV 5mg/kg (Part 1) | Descriptive Statistics for Actual Value in Fecal Calprotectin Concentration (Pharmacodynamic Parameter) (Part 2) | Week 6 | 735.3 μg/g | Standard Deviation 1329.11 |
| Cohort 1: CT-P13 IV 5mg/kg (Part 1) | Descriptive Statistics for Actual Value in Fecal Calprotectin Concentration (Pharmacodynamic Parameter) (Part 2) | Week 46 | 354.2 μg/g | Standard Deviation 628.37 |
| Cohort 1: CT-P13 IV 5mg/kg (Part 1) | Descriptive Statistics for Actual Value in Fecal Calprotectin Concentration (Pharmacodynamic Parameter) (Part 2) | Week 22 | 796.8 μg/g | Standard Deviation 1950.69 |
| Cohort 1: CT-P13 IV 5mg/kg (Part 1) | Descriptive Statistics for Actual Value in Fecal Calprotectin Concentration (Pharmacodynamic Parameter) (Part 2) | Week 54 | 484.1 μg/g | Standard Deviation 1216.95 |
| Cohort 1: CT-P13 IV 5mg/kg (Part 1) | Descriptive Statistics for Actual Value in Fecal Calprotectin Concentration (Pharmacodynamic Parameter) (Part 2) | Baseline | 2094.2 μg/g | Standard Deviation 4114.17 |
| Cohort 2: CT-P13 SC 120 mg (Part 1) | Descriptive Statistics for Actual Value in Fecal Calprotectin Concentration (Pharmacodynamic Parameter) (Part 2) | Week 54 | 256.2 μg/g | Standard Deviation 520.12 |
| Cohort 2: CT-P13 SC 120 mg (Part 1) | Descriptive Statistics for Actual Value in Fecal Calprotectin Concentration (Pharmacodynamic Parameter) (Part 2) | Baseline | 2605.2 μg/g | Standard Deviation 8757.77 |
| Cohort 2: CT-P13 SC 120 mg (Part 1) | Descriptive Statistics for Actual Value in Fecal Calprotectin Concentration (Pharmacodynamic Parameter) (Part 2) | Week 2 | 455.0 μg/g | Standard Deviation 561.73 |
| Cohort 2: CT-P13 SC 120 mg (Part 1) | Descriptive Statistics for Actual Value in Fecal Calprotectin Concentration (Pharmacodynamic Parameter) (Part 2) | Week 6 | 567.3 μg/g | Standard Deviation 956.14 |
| Cohort 2: CT-P13 SC 120 mg (Part 1) | Descriptive Statistics for Actual Value in Fecal Calprotectin Concentration (Pharmacodynamic Parameter) (Part 2) | Week 14 | 706.1 μg/g | Standard Deviation 968 |
| Cohort 2: CT-P13 SC 120 mg (Part 1) | Descriptive Statistics for Actual Value in Fecal Calprotectin Concentration (Pharmacodynamic Parameter) (Part 2) | Week 22 | 1137.0 μg/g | Standard Deviation 2510.62 |
| Cohort 2: CT-P13 SC 120 mg (Part 1) | Descriptive Statistics for Actual Value in Fecal Calprotectin Concentration (Pharmacodynamic Parameter) (Part 2) | Week 30 | 603.1 μg/g | Standard Deviation 905.6 |
| Cohort 2: CT-P13 SC 120 mg (Part 1) | Descriptive Statistics for Actual Value in Fecal Calprotectin Concentration (Pharmacodynamic Parameter) (Part 2) | Week 38 | 505.3 μg/g | Standard Deviation 866.04 |
| Cohort 2: CT-P13 SC 120 mg (Part 1) | Descriptive Statistics for Actual Value in Fecal Calprotectin Concentration (Pharmacodynamic Parameter) (Part 2) | Week 46 | 552.2 μg/g | Standard Deviation 1451.62 |
Secondary
Descriptive Statistics for Actual Value of Crohn's Disease Activity Index (CDAI) Score (Part 2 - CD)
For evaluation of efficacy, the secondary endpoint was defined as descriptive statistics for actual value of CDAI score up to Week 54 between the CT-P13 SC and CT-P13 IV treatment groups in active CD patients. The total CDAI scores range from 0 to over 600 with higher scores indicating increased severity of disease. The index is the sum of 8 components multiplied by the relevant weight factor; number of liquid or very soft stools (x2), abdominal pain (x5), general well-being (x7), CD complications (x20), taking lomotil/opiates for diarrhea (x30), abdominal mass (x10), deviation of hematocrit (x6), and percentage deviation from standard weight (x1). Efficacy assessments were done prior to each study drug administrations. Results up to Week 6 in both arms represent efficacy resulting from CT-P13 IV (5 mg/kg) loading dose treatment.
Time frame: up to Week 54
Population: The efficacy population consisted of the all randomly assigned patients who received at least 1 full dose of study drug (CT-P13 SC or CT-P13 IV) at Week 6 or thereafter and who had at least 1 efficacy evaluation result after Week 6 treatment. All patients in the efficacy population were analyzed according to the treatment they received.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: CT-P13 IV 5mg/kg (Part 1) | Descriptive Statistics for Actual Value of Crohn's Disease Activity Index (CDAI) Score (Part 2 - CD) | Week 22 | 106.55 scores on a scale | Standard Deviation 80.461 |
| Cohort 1: CT-P13 IV 5mg/kg (Part 1) | Descriptive Statistics for Actual Value of Crohn's Disease Activity Index (CDAI) Score (Part 2 - CD) | Week 30 | 103.81 scores on a scale | Standard Deviation 88.435 |
| Cohort 1: CT-P13 IV 5mg/kg (Part 1) | Descriptive Statistics for Actual Value of Crohn's Disease Activity Index (CDAI) Score (Part 2 - CD) | Week 54 | 92.03 scores on a scale | Standard Deviation 77.622 |
| Cohort 1: CT-P13 IV 5mg/kg (Part 1) | Descriptive Statistics for Actual Value of Crohn's Disease Activity Index (CDAI) Score (Part 2 - CD) | Baseline | 296.38 scores on a scale | Standard Deviation 59.212 |
| Cohort 1: CT-P13 IV 5mg/kg (Part 1) | Descriptive Statistics for Actual Value of Crohn's Disease Activity Index (CDAI) Score (Part 2 - CD) | Week 2 | 194.89 scores on a scale | Standard Deviation 74.943 |
| Cohort 1: CT-P13 IV 5mg/kg (Part 1) | Descriptive Statistics for Actual Value of Crohn's Disease Activity Index (CDAI) Score (Part 2 - CD) | Week 6 | 164.99 scores on a scale | Standard Deviation 96.36 |
| Cohort 1: CT-P13 IV 5mg/kg (Part 1) | Descriptive Statistics for Actual Value of Crohn's Disease Activity Index (CDAI) Score (Part 2 - CD) | Week 14 | 136.29 scores on a scale | Standard Deviation 85.918 |
| Cohort 2: CT-P13 SC 120 mg (Part 1) | Descriptive Statistics for Actual Value of Crohn's Disease Activity Index (CDAI) Score (Part 2 - CD) | Week 22 | 105.08 scores on a scale | Standard Deviation 60.97 |
| Cohort 2: CT-P13 SC 120 mg (Part 1) | Descriptive Statistics for Actual Value of Crohn's Disease Activity Index (CDAI) Score (Part 2 - CD) | Week 2 | 191.03 scores on a scale | Standard Deviation 79.25 |
| Cohort 2: CT-P13 SC 120 mg (Part 1) | Descriptive Statistics for Actual Value of Crohn's Disease Activity Index (CDAI) Score (Part 2 - CD) | Week 30 | 106.44 scores on a scale | Standard Deviation 67.705 |
| Cohort 2: CT-P13 SC 120 mg (Part 1) | Descriptive Statistics for Actual Value of Crohn's Disease Activity Index (CDAI) Score (Part 2 - CD) | Week 14 | 131.47 scores on a scale | Standard Deviation 71.444 |
| Cohort 2: CT-P13 SC 120 mg (Part 1) | Descriptive Statistics for Actual Value of Crohn's Disease Activity Index (CDAI) Score (Part 2 - CD) | Week 54 | 79.05 scores on a scale | Standard Deviation 58.96 |
| Cohort 2: CT-P13 SC 120 mg (Part 1) | Descriptive Statistics for Actual Value of Crohn's Disease Activity Index (CDAI) Score (Part 2 - CD) | Week 6 | 144.94 scores on a scale | Standard Deviation 80.123 |
| Cohort 2: CT-P13 SC 120 mg (Part 1) | Descriptive Statistics for Actual Value of Crohn's Disease Activity Index (CDAI) Score (Part 2 - CD) | Baseline | 294.75 scores on a scale | Standard Deviation 59.899 |
Secondary
Descriptive Statistics for Actual Value of Partial Mayo Score (Part 2 - UC)
For evaluation of efficacy, the secondary endpoint was defined as descriptive statistics for actual value of partial Mayo score up to Week 54 between the CT-P13 SC and CT-P13 IV treatment groups in active UC patients. The partial Mayo scores range from 0-9 with higher scores indicating increased severity of disease. The index is sum of the 3 subscores, each which range from 0 to 3; stool frequency, rectal bleeding and physician's global assessment. Efficacy assessments were done prior to each study drug administrations. Results up to Week 6 in both arms represent efficacy resulting from CT-P13 IV (5 mg/kg) loading dose treatment.
Time frame: up to Week 54
Population: The efficacy population consisted of the all randomly assigned patients who received at least 1 full dose of study drug (CT-P13 SC or CT-P13 IV) at Week 6 or thereafter and who had at least 1 efficacy evaluation result after Week 6 treatment. All patients in the efficacy population were analyzed according to the treatment they received.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: CT-P13 IV 5mg/kg (Part 1) | Descriptive Statistics for Actual Value of Partial Mayo Score (Part 2 - UC) | Week 6 | 2.6 scores on a scale | Standard Deviation 2.13 |
| Cohort 1: CT-P13 IV 5mg/kg (Part 1) | Descriptive Statistics for Actual Value of Partial Mayo Score (Part 2 - UC) | Week 22 | 1.3 scores on a scale | Standard Deviation 1.63 |
| Cohort 1: CT-P13 IV 5mg/kg (Part 1) | Descriptive Statistics for Actual Value of Partial Mayo Score (Part 2 - UC) | Week 2 | 3.3 scores on a scale | Standard Deviation 2.18 |
| Cohort 1: CT-P13 IV 5mg/kg (Part 1) | Descriptive Statistics for Actual Value of Partial Mayo Score (Part 2 - UC) | Week 30 | 1.2 scores on a scale | Standard Deviation 1.59 |
| Cohort 1: CT-P13 IV 5mg/kg (Part 1) | Descriptive Statistics for Actual Value of Partial Mayo Score (Part 2 - UC) | Week 14 | 1.7 scores on a scale | Standard Deviation 1.62 |
| Cohort 1: CT-P13 IV 5mg/kg (Part 1) | Descriptive Statistics for Actual Value of Partial Mayo Score (Part 2 - UC) | Week 54 | 0.9 scores on a scale | Standard Deviation 1.31 |
| Cohort 1: CT-P13 IV 5mg/kg (Part 1) | Descriptive Statistics for Actual Value of Partial Mayo Score (Part 2 - UC) | Baseline | 5.4 scores on a scale | Standard Deviation 1.31 |
| Cohort 2: CT-P13 SC 120 mg (Part 1) | Descriptive Statistics for Actual Value of Partial Mayo Score (Part 2 - UC) | Week 54 | 1.0 scores on a scale | Standard Deviation 1.6 |
| Cohort 2: CT-P13 SC 120 mg (Part 1) | Descriptive Statistics for Actual Value of Partial Mayo Score (Part 2 - UC) | Baseline | 5.9 scores on a scale | Standard Deviation 1.21 |
| Cohort 2: CT-P13 SC 120 mg (Part 1) | Descriptive Statistics for Actual Value of Partial Mayo Score (Part 2 - UC) | Week 2 | 3.3 scores on a scale | Standard Deviation 1.82 |
| Cohort 2: CT-P13 SC 120 mg (Part 1) | Descriptive Statistics for Actual Value of Partial Mayo Score (Part 2 - UC) | Week 6 | 2.5 scores on a scale | Standard Deviation 1.74 |
| Cohort 2: CT-P13 SC 120 mg (Part 1) | Descriptive Statistics for Actual Value of Partial Mayo Score (Part 2 - UC) | Week 14 | 2.3 scores on a scale | Standard Deviation 1.92 |
| Cohort 2: CT-P13 SC 120 mg (Part 1) | Descriptive Statistics for Actual Value of Partial Mayo Score (Part 2 - UC) | Week 22 | 2.3 scores on a scale | Standard Deviation 1.97 |
| Cohort 2: CT-P13 SC 120 mg (Part 1) | Descriptive Statistics for Actual Value of Partial Mayo Score (Part 2 - UC) | Week 30 | 1.9 scores on a scale | Standard Deviation 1.88 |
Secondary
Descriptive Statistics of Observed Ctrough (Trough Concentration [Before the Next Study Drug Administration]) of Infliximab (Part 2)
For evaluation of pharmacokinetics (PK), the secondary endpoint was defined as the analysis of trough concentration of infliximab up to Week 54. The samples were collected at Weeks 0, 2 and 6, and every 8 weeks up to Week 54. During PK monitoring visit (Weeks 22-30), samples were collected every 2 weeks according steady state PK sampling time point. All enrolled patient received CT-P13 IV infusions at Weeks 0 and 2. Patients in SC group were administered with CT-P13 SC at Week 6 and every 2 weeks thereafter up to Week 54. Patients in IV group were administered with CT-P13 IV at Week 6 and every 8 weeks thereafter up to Week 22. Then, CT-P13 IV was switched to CT-P13 SC at Week 30, and further doses with CT-P13 SC were given up to Week 54. No PK results were obtained at Weeks 6 and 14 for SC group and Weeks 12, 20, 24, 26 and 28 for IV group due to 2 weeks and 8 weeks dosing interval, respectively. All patients in PK population were analyzed according to the treatment they received.
Time frame: up to Week 54
Population: The PK population consisted of the all-randomized population who received at least one full dose of study drug at Week 6 or thereafter and who had at least one PK concentration result after Week 6 treatment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: CT-P13 IV 5mg/kg (Part 1) | Descriptive Statistics of Observed Ctrough (Trough Concentration [Before the Next Study Drug Administration]) of Infliximab (Part 2) | Week 26 | 22.3410 μg/mL | Standard Deviation 9.81672 |
| Cohort 1: CT-P13 IV 5mg/kg (Part 1) | Descriptive Statistics of Observed Ctrough (Trough Concentration [Before the Next Study Drug Administration]) of Infliximab (Part 2) | Week 28 | 21.0978 μg/mL | Standard Deviation 8.98618 |
| Cohort 1: CT-P13 IV 5mg/kg (Part 1) | Descriptive Statistics of Observed Ctrough (Trough Concentration [Before the Next Study Drug Administration]) of Infliximab (Part 2) | Week 36 | 22.1927 μg/mL | Standard Deviation 9.97943 |
| Cohort 1: CT-P13 IV 5mg/kg (Part 1) | Descriptive Statistics of Observed Ctrough (Trough Concentration [Before the Next Study Drug Administration]) of Infliximab (Part 2) | Week 2 | 15.4736 μg/mL | Standard Deviation 9.15888 |
| Cohort 1: CT-P13 IV 5mg/kg (Part 1) | Descriptive Statistics of Observed Ctrough (Trough Concentration [Before the Next Study Drug Administration]) of Infliximab (Part 2) | Week 44 | 22.5780 μg/mL | Standard Deviation 11.72637 |
| Cohort 1: CT-P13 IV 5mg/kg (Part 1) | Descriptive Statistics of Observed Ctrough (Trough Concentration [Before the Next Study Drug Administration]) of Infliximab (Part 2) | Week 20 | 21.4500 μg/mL | Standard Deviation 9.86306 |
| Cohort 1: CT-P13 IV 5mg/kg (Part 1) | Descriptive Statistics of Observed Ctrough (Trough Concentration [Before the Next Study Drug Administration]) of Infliximab (Part 2) | Week 52 | 22.7928 μg/mL | Standard Deviation 13.17095 |
| Cohort 1: CT-P13 IV 5mg/kg (Part 1) | Descriptive Statistics of Observed Ctrough (Trough Concentration [Before the Next Study Drug Administration]) of Infliximab (Part 2) | Week 0 | 23.5432 μg/mL | Standard Deviation 8.43542 |
| Cohort 1: CT-P13 IV 5mg/kg (Part 1) | Descriptive Statistics of Observed Ctrough (Trough Concentration [Before the Next Study Drug Administration]) of Infliximab (Part 2) | Week 22 | 19.6786 μg/mL | Standard Deviation 8.94416 |
| Cohort 1: CT-P13 IV 5mg/kg (Part 1) | Descriptive Statistics of Observed Ctrough (Trough Concentration [Before the Next Study Drug Administration]) of Infliximab (Part 2) | Week 12 | 20.9700 μg/mL | Standard Deviation 9.21851 |
| Cohort 1: CT-P13 IV 5mg/kg (Part 1) | Descriptive Statistics of Observed Ctrough (Trough Concentration [Before the Next Study Drug Administration]) of Infliximab (Part 2) | Week 24 | 20.1528 μg/mL | Standard Deviation 10.53981 |
| Cohort 2: CT-P13 SC 120 mg (Part 1) | Descriptive Statistics of Observed Ctrough (Trough Concentration [Before the Next Study Drug Administration]) of Infliximab (Part 2) | Week 52 | 20.5784 μg/mL | Standard Deviation 12.45367 |
| Cohort 2: CT-P13 SC 120 mg (Part 1) | Descriptive Statistics of Observed Ctrough (Trough Concentration [Before the Next Study Drug Administration]) of Infliximab (Part 2) | Week 0 | 21.8589 μg/mL | Standard Deviation 7.36954 |
| Cohort 2: CT-P13 SC 120 mg (Part 1) | Descriptive Statistics of Observed Ctrough (Trough Concentration [Before the Next Study Drug Administration]) of Infliximab (Part 2) | Week 2 | 14.0747 μg/mL | Standard Deviation 7.7407 |
| Cohort 2: CT-P13 SC 120 mg (Part 1) | Descriptive Statistics of Observed Ctrough (Trough Concentration [Before the Next Study Drug Administration]) of Infliximab (Part 2) | Week 6 | 3.7865 μg/mL | Standard Deviation 2.99669 |
| Cohort 2: CT-P13 SC 120 mg (Part 1) | Descriptive Statistics of Observed Ctrough (Trough Concentration [Before the Next Study Drug Administration]) of Infliximab (Part 2) | Week 14 | 2.9317 μg/mL | Standard Deviation 2.60859 |
| Cohort 2: CT-P13 SC 120 mg (Part 1) | Descriptive Statistics of Observed Ctrough (Trough Concentration [Before the Next Study Drug Administration]) of Infliximab (Part 2) | Week 22 | 2.4273 μg/mL | Standard Deviation 2.49468 |
| Cohort 2: CT-P13 SC 120 mg (Part 1) | Descriptive Statistics of Observed Ctrough (Trough Concentration [Before the Next Study Drug Administration]) of Infliximab (Part 2) | Week 36 | 18.5974 μg/mL | Standard Deviation 11.41166 |
| Cohort 2: CT-P13 SC 120 mg (Part 1) | Descriptive Statistics of Observed Ctrough (Trough Concentration [Before the Next Study Drug Administration]) of Infliximab (Part 2) | Week 44 | 19.6401 μg/mL | Standard Deviation 10.48885 |
Secondary
Proportion of Patients Achieving Clinical Response According to CDAI-100 Criteria (Part 2 - CD)
For evaluation of efficacy, the secondary endpoint was defined as proportion of patients achieving clinical response according to CDAI-100 criteria up to Week 54 between the CT-P13 SC and CT-P13 IV treatment groups in active CD patients. Efficacy assessments were done prior to each study drug administrations. Results up to Week 6 in both arms represent efficacy resulting from CT-P13 IV (5 mg/kg) loading dose treatment. Responder according to CDAI-100 criteria was defined as a decrease in CDAI score of 100 points or more from the baseline value.
Time frame: up to Week 54
Population: The efficacy population consisted of the all randomly assigned patients who received at least 1 full dose of study drug (CT-P13 SC or CT-P13 IV) at Week 6 or thereafter and who had at least 1 efficacy evaluation result after Week 6 treatment. All patients in the efficacy population were analyzed according to the treatment they received.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: CT-P13 IV 5mg/kg (Part 1) | Proportion of Patients Achieving Clinical Response According to CDAI-100 Criteria (Part 2 - CD) | Week 2 | 13 Participants |
| Cohort 1: CT-P13 IV 5mg/kg (Part 1) | Proportion of Patients Achieving Clinical Response According to CDAI-100 Criteria (Part 2 - CD) | Week 6 | 16 Participants |
| Cohort 1: CT-P13 IV 5mg/kg (Part 1) | Proportion of Patients Achieving Clinical Response According to CDAI-100 Criteria (Part 2 - CD) | Week 14 | 19 Participants |
| Cohort 1: CT-P13 IV 5mg/kg (Part 1) | Proportion of Patients Achieving Clinical Response According to CDAI-100 Criteria (Part 2 - CD) | Week 22 | 21 Participants |
| Cohort 1: CT-P13 IV 5mg/kg (Part 1) | Proportion of Patients Achieving Clinical Response According to CDAI-100 Criteria (Part 2 - CD) | Week 30 | 19 Participants |
| Cohort 1: CT-P13 IV 5mg/kg (Part 1) | Proportion of Patients Achieving Clinical Response According to CDAI-100 Criteria (Part 2 - CD) | Week 54 | 18 Participants |
| Cohort 2: CT-P13 SC 120 mg (Part 1) | Proportion of Patients Achieving Clinical Response According to CDAI-100 Criteria (Part 2 - CD) | Week 30 | 16 Participants |
| Cohort 2: CT-P13 SC 120 mg (Part 1) | Proportion of Patients Achieving Clinical Response According to CDAI-100 Criteria (Part 2 - CD) | Week 2 | 9 Participants |
| Cohort 2: CT-P13 SC 120 mg (Part 1) | Proportion of Patients Achieving Clinical Response According to CDAI-100 Criteria (Part 2 - CD) | Week 22 | 20 Participants |
| Cohort 2: CT-P13 SC 120 mg (Part 1) | Proportion of Patients Achieving Clinical Response According to CDAI-100 Criteria (Part 2 - CD) | Week 6 | 17 Participants |
| Cohort 2: CT-P13 SC 120 mg (Part 1) | Proportion of Patients Achieving Clinical Response According to CDAI-100 Criteria (Part 2 - CD) | Week 54 | 16 Participants |
| Cohort 2: CT-P13 SC 120 mg (Part 1) | Proportion of Patients Achieving Clinical Response According to CDAI-100 Criteria (Part 2 - CD) | Week 14 | 18 Participants |
Secondary
Proportion of Patients Achieving Clinical Response According to the Partial Mayo Score (Part 2 - UC)
For evaluation of efficacy, the secondary endpoint was defined as proportion of patients achieving clinical response according to the partial Mayo score up to Week 54 between the CT-P13 SC and CT-P13 IV treatment groups in active UC patients. Efficacy assessments were done prior to each study drug administrations. Results up to Week 6 in both arms represent efficacy resulting from CT-P13 IV (5 mg/kg) loading dose treatment. Responder according to partial Mayo score was defined as a decrease from baseline in partial Mayo score of at least 2 points, with an accompanying decrease in the subscore for rectal bleeding of at least 1 point or an absolute subscore for rectal bleeding of 0 or 1.
Time frame: up to Week 54
Population: The efficacy population consisted of the all randomly assigned patients who received at least 1 full dose of study drug (CT-P13 SC or CT-P13 IV) at Week 6 or thereafter and who had at least 1 efficacy evaluation result after Week 6 treatment. All patients in the efficacy population were analyzed according to the treatment they received.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: CT-P13 IV 5mg/kg (Part 1) | Proportion of Patients Achieving Clinical Response According to the Partial Mayo Score (Part 2 - UC) | Week 2 | 20 Participants |
| Cohort 1: CT-P13 IV 5mg/kg (Part 1) | Proportion of Patients Achieving Clinical Response According to the Partial Mayo Score (Part 2 - UC) | Week 6 | 28 Participants |
| Cohort 1: CT-P13 IV 5mg/kg (Part 1) | Proportion of Patients Achieving Clinical Response According to the Partial Mayo Score (Part 2 - UC) | Week 14 | 30 Participants |
| Cohort 1: CT-P13 IV 5mg/kg (Part 1) | Proportion of Patients Achieving Clinical Response According to the Partial Mayo Score (Part 2 - UC) | Week 22 | 32 Participants |
| Cohort 1: CT-P13 IV 5mg/kg (Part 1) | Proportion of Patients Achieving Clinical Response According to the Partial Mayo Score (Part 2 - UC) | Week 30 | 33 Participants |
| Cohort 1: CT-P13 IV 5mg/kg (Part 1) | Proportion of Patients Achieving Clinical Response According to the Partial Mayo Score (Part 2 - UC) | Week 54 | 31 Participants |
| Cohort 2: CT-P13 SC 120 mg (Part 1) | Proportion of Patients Achieving Clinical Response According to the Partial Mayo Score (Part 2 - UC) | Week 30 | 29 Participants |
| Cohort 2: CT-P13 SC 120 mg (Part 1) | Proportion of Patients Achieving Clinical Response According to the Partial Mayo Score (Part 2 - UC) | Week 2 | 25 Participants |
| Cohort 2: CT-P13 SC 120 mg (Part 1) | Proportion of Patients Achieving Clinical Response According to the Partial Mayo Score (Part 2 - UC) | Week 22 | 30 Participants |
| Cohort 2: CT-P13 SC 120 mg (Part 1) | Proportion of Patients Achieving Clinical Response According to the Partial Mayo Score (Part 2 - UC) | Week 6 | 31 Participants |
| Cohort 2: CT-P13 SC 120 mg (Part 1) | Proportion of Patients Achieving Clinical Response According to the Partial Mayo Score (Part 2 - UC) | Week 54 | 28 Participants |
| Cohort 2: CT-P13 SC 120 mg (Part 1) | Proportion of Patients Achieving Clinical Response According to the Partial Mayo Score (Part 2 - UC) | Week 14 | 33 Participants |